OraSure Technologies Inc
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Health Care : Health Care Equipment & Supplies | Small Cap Blend
Company profile

OraSure Technologies, Inc. (OraSure) is involved in the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using its technologies, as well as other diagnostic products, including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Company operates in two segments: OSUR and DNAG. OSUR consists of the development, manufacture and sale of diagnostic products, specimen collection devices, and medical devices. DNAG or molecular collection systems business consists primarily of the development, manufacture and sale of oral fluid collection devices that are used to collect, stabilize, and store samples of genetic material for molecular testing.

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Today's volume of 19,969 shares is on pace to be much lighter than OSUR's 10-day average volume of 1,337,196 shares.


OraSure Technologies, Inc. Announces First Quarter 2021 Financial Results and Provides COVID-19 Update

4:00 pm ET May 5, 2021 (Globe Newswire) Print

First Quarter 2021 Net Revenues of $59 Million Increased 85% Over 2020, Driven by $27 Million in Sales of Sample Collection Devices for COVID-19 Molecular Testing

EUA Application Submitted in Q1 to FDA for COVID-19 Rapid Antigen Test for Both Prescription Home Use and Professional Use in Point of Care Settings

Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET

OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its financial results for the three months ended March 31, 2021.

"OraSure had another strong quarter, as the Company delivered double-digit year-over-year revenue growth for the third quarter in a row. Our sample collection devices for COVID-19 molecular testing continue to make a significant contribution to our revenues. Moreover, we have submitted our COVID-19 rapid antigen test to the US Food and Drug Administration for Emergency Use Authorization, and look forward to bringing a prescription home test and a professional test for point of care use to market," said Stephen Tang, Ph.D., President and CEO of OraSure Technologies.

Dr. Tang continued, "As coronavirus variants continue to spread, we believe convenient, safe and accurate COVID-19 testing will continue to play a key role in identifying those who are infected and helping to safely reopen workplaces, schools, and other places where people gather. We are confident in the market potential for our COVID products, as well as the resilience of our other business segments as demonstrated by the strong first quarter performance of our commercial genomics, microbiome, and domestic HIV testing business. Given the overall strong financial performance of our business, the EUA applications pending before the FDA and our solid financial foundation, we are confident that OraSure is well positioned for continued success."

Financial Highlights

COVID-19 Update




-- OraSure has collected all the data necessary to resubmit the two requested EUA applications for its oral fluid antibody test. At the FDA's request, the Company plans to submit separate EUAs for the ELISA microplate assay and the OraSure Oral Antibody Collection Device.

  • To date, no oral fluid antibody tests have received EUA; OraSure's test has the potential to be the first.


    Financial Results for the Three Months Ended March 31, 2021

    Net revenues for the first quarter of 2021 of $58.6 million increased 85% from the comparable period of 2020, primarily as a result of strong sales of molecular sample collection kits for COVID-19 testing, higher genomics product sales and increased sales by the Company's domestic HIV testing business, partially offset by declines in revenues of our international HIV products due to order timing and risk assessment products due to the impact of COVID-19 on the overall risk assessment testing market in the US.

    Gross profit percentage was 65% for the three months ended March 31, 2021 compared to 51% for the three months ended March 31, 2020. Gross profit in the current quarter benefited from an improved product mix associated with higher gross profit percentage product sales.

    For the three months ended March 31, 2021, operating expenses were $27.9 million, an increase of $3.7 million from the $24.2 million reported for the three months ended March 31, 2020, largely due to increased investment in the development and sale of the Company's COVID products. Operating expenses were also impacted by a benefit of $806,000 representing the change in the estimated fair value of acquisition-related contingent consideration compared to an expense of $1.1 million recorded the same period of 2020.

    The Company generated operating income of $10.4 million in the first quarter of 2021 compared to an operating loss of $8.1 million in the first quarter of 2020.

    During the first quarters of 2021 and 2020, the Company recorded income tax expense of $6.5 million and $712,000, respectively.

    Second Quarter 2021 Guidance

    The Company expects second quarter 2021 net revenues to range from $55 million to $60 million.

    Financial Data (Unaudited)

                                                                         Three Months Ended
                                                                         March 31,
                                                                         2021          2020
    Results of Operations
    Net revenues                                                         $  58,582     $  31,596
    Cost of products and services sold                                      20,256        15,465
    Gross profit                                                            38,326        16,131
    Operating expenses:
    Research and development                                                8,992         5,644
    Sales and marketing                                                     9,530         7,369
    General and administrative                                              10,188        10,054
    Change in fair value of acquisition-related contingent consideration    (806   )      1,110
    Total operating expenses                                                27,904        24,177
    Operating income (loss)                                                 10,422        (8,046 )
    Other income (expense)                                                  (119   )      1,430
    Income (loss) before income taxes                                       10,303        (6,616 )
    Income tax expense                                                      6,529         712
    Net income (loss)                                                    $  3,774      $  (7,328 )
    Earnings (loss) per share:
    Basic                                                                $  0.05       $  (0.12  )
    Diluted                                                              $  0.05       $  (0.12  )
    Weighted average shares:
    Basic                                                                   71,878        61,927
    Diluted                                                                 72,766        61,927
                                     Three Months Ended March 31,
                                     Dollars                           Percentage of Total
                                                                       Net Revenues
                                     2021       2020       %           2021       2020
    Infectious disease testing       $  11,371  $  14,664  (22 )   %   20   %     46       %
    Risk assessment testing             1,962      3,000   (35 )       3          9
    Molecular solutions                 43,246     13,222  227         74         43
    Net product and service revenues    56,579     30,886  83          97         98
    Other                               2,003      710     182         3          2
    Net revenues                     $  58,582  $  31,596  85      %   100  %     100      %
                                        Three Months Ended
                                        March 31,
                                        2021       2020       %
    Infectious Disease Testing Revenues
    Domestic HIV                        $  5,293   $  4,216   26      %
    International HIV                      3,486      6,949   (50 )
    Net HIV revenues                       8,779      11,165  (21 )
    Domestic HCV                           1,182      1,494   (21 )
    International HCV                      1,184      1,097   8
    Net HCV revenues                       2,366      2,591   (9  )
    Other product revenues                 226        908     (75 )
    Net product revenues                $  11,371  $  14,664  (22 )   %
                                       Three Months Ended
                                       March 31,
                                       2021        2020       %
    Molecular Solutions Revenues
    Genomics                           $  11,064   $  8,393   32      %
    Microbiome                            2,088       1,577   32
    COVID-19                              27,389      394     N/A
    Laboratory services                   2,497       2,415   3
    Other product and service revenues    208         443     (53 )
    Net product and service revenues      43,246      13,222  227
    Other                                 790         582     36
    Net revenues                       $  44,036   $  13,804  219     %
    Condensed Consolidated Balance Sheets (Unaudited)
                                                      March 31, 2021   December 31, 2020
    Cash and cash equivalents                         $       177,676  $        160,802
    Short-term investments                                    29,080            48,599
    Accounts receivable, net                                  36,391            38,835
    Inventories                                               40,348            31,863
    Other current assets                                      8,913             8,794
    Property, plant and equipment, net                        64,943            51,860
    Intangible assets, net                                    16,945            17,904
    Goodwill                                                  40,493            40,351
    Long-term investments                                     33,706            47,718
    Other non-current assets                                  7,999             7,746
    Total assets                                      $       456,494  $        454,472
    Liabilities and Stockholders' Equity
    Accounts payable                                  $       20,731   $        17,407
    Deferred revenue                                          4,580             4,811
    Contingent consideration obligation                       365               402
    Other current liabilities                                 18,967            23,869
    Non-current contingent consideration obligation           874               2,049
    Other non-current liabilities                             7,434             7,363
    Stockholders' equity                                      403,543           398,571
    Total liabilities and stockholders' equity        $       456,494  $        454,472
    Additional Financial Data (Unaudited)           Three Months Ended
                                                    March 31,
                                                    2021            2020
    Capital expenditures                            $   11,061      $   2,595
    Depreciation and amortization                   $   2,489       $   2,165
    Stock-based compensation                        $   1,464       $   1,376
    Cash provided by (used in) operating activities $   (4,393 )    $   2,499

    Conference Call

    The Company will host a conference call and audio webcast for analysts and investors to discuss the Company's first quarter 2021 quarter results and certain business developments, beginning today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Dr. Stephen S. Tang, President and Chief Executive Officer, and Roberto Cuca, Chief Financial Officer. The call will include prepared remarks by management and a question and answer session.

    In order to listen to the conference call, please dial 844-831-3030 (Domestic) or 315-625-6887 (International) and reference Conference ID # 1349536 or go to OraSure Technologies' web site, www.orasure.com, and click on the Investor Relations page. Please click on the webcast link and follow the prompts for registration and access 10 minutes prior to the call. A replay of the call will be archived on OraSure Technologies' web site shortly after the call has ended and will be available for 14 days. A replay of the call can also be accessed until midnight, May 19, 2021, by dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and entering the Conference ID # 1349536.

    It is recommended to dial-in at most 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on OraSure's Investor Relations page.

    About OraSure Technologies

    OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure's portfolio of products is sold globally to clinical laboratories, hospitals, physician's offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

    Important Information

    This press release contains certain forward-looking statements, including with respect to expected revenues, products, product development activities, regulatory submissions and authorizations and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management's attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration ("FDA") or other regulators; the impact of the novel coronavirus ("COVID-19") pandemic on our business and our ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company's products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention ("CDC") or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company's stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2020, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

    Investor Contact:         Media Contact
    Sam Martin                Jeanne Mell
    Argot Partners            OraSure Technologies
    212-600-1902              484-353-1575
    orasure@argotpartners.com media@orasure.com



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